The EU has published documents laying out extraordinary measures that could be taken to give faster access to drugs by bypassing patent rights in emergencies and bring production directly to Europe.
The proposal has been put forward to address the chronic problem of medicine shortages in the bloc, which has been exacerbated by the ongoing coronavirus outbreak – and the trade disruptions it has caused.
The four ‘pillar’ strategy detailed by the European Commission is aimed at streamlining the process to ensure generic drugs can be produced at a faster rate, enhancing crisis preparedness and response mechanisms as well as addressing the security of supply – without having to secure the consent of the patent holders.
Margaritis Schinas, vice president for the Commission’s ‘Promoting the European Way of Life’ policy area, told reporters that the proposal “supports the EU’s pharmaceutical industry to remain competitive and innovative, whilst addressing the needs of the patients and those of our health systems.”
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The European Commission explained that while the newly released strategy draws lessons from the current Covid-19 pandemic, it aims to be more than a crisis-response tool, and instead should help make the bloc’s pharmaceutical sector both better prepared and more resilient.
The system, known as compulsory licensing, is currently allowed under World Trade Organization rules in extraordinary circumstances, such as the current pandemic.
While the EU has the ability to use the WTO waiver, which “allows someone else to produce the patented product or process without the consent of the patent owner”, it has so far resisted calls from lawmakers to do so, instead agreeing billion-euro deals with pharmaceutical companies.
Before the EU proceeds further, the strategy will be discussed at the Employment, Social Policy, Health and Consumer Affairs Council Meeting which is due to take place on December 2, allowing member states to weigh in on the proposal.
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